UMIN-CTR Clinical Trial

Public title

Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma(JCOG0110, GCSSG-SPNX)

Acronym

Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma(JCOG0110, GCSSG-SPNX)

Scientific Title

Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma(JCOG0110, GCSSG-SPNX)

Scientific Title:Acronym

Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma(JCOG0110, GCSSG-SPNX)

Region

Japan

Condition

T2, T3, and T4 carcinoma in the proximal third of the stomach

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the role of splenectomy in potentially curative total gastrectomy for proximal gastric carcinoma in terms of survival benefit and post-operative morbidity.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

overall survival

Key secondary outcomes

relapse-free survival, post-operative morbidity, operation time and perioperative blood loss

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

A:Surgery:splenectomy

Interventions/Control_2

B:Surgery:spleen-preservation

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

Preoperatively,
(1) histologically proven adenocarcinoma
(2)T2 or deeper lesion in the upper third of the stomach without involvement of the greater curvature or esophageal invasion more than 3 cm, irrespective of the primary tumor location or existence of multiple foci
(3) no distant metastasis, not linitis plastica ('Borrmann 4'), not stump carcinoma, no prior treatment for 364 Randomized trial for splenectomy gastric cancer
(4) sufficient organ function
(5) written informed consent.
Intra-operatively,
(6) T2/T3/T4 and N0/N1/N2, no tumor on the greater curvature, no direct invasion of the pancreas or spleen, negative peritoneal lavage cytology
(7) no apparent nodal metastasis in the splenic hilum or along the splenic artery

Key exclusion criteria

(1) Liver cirrhosis or portal hypertension
(2) idiopathic thrombocytopenic purpura
(3) severe pulmonary dysfunction
(4)synchronous or metachronous (within 5 years) malignancy

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Mitsuru Sasako, MD, PhD

Organization

Hyogo College of Medicine

Division name

Upper GI Surgery Division

Zip code

Address

1-1 Mukogawacho, Nishinomiya, Hyogo, Japan

TEL

0798-45-6767

Email

msasako@hyo-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Takeshi Sano, MD, PhD

Organization

JCOG0110 Coordinating Office

Division name

Gastroenterological Surgery, Cancer Institute Hospital

Zip code

Address

3-10-6, Ariake, Koto-ku, Tokyo, 135-8550, JAPAN

TEL

03-3520-0111

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

NCT00112099

Org. issuing International ID_1

ClinicalTrials.gov by NLM

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

函館厚生院函館五稜郭病院（北海道）
岩手医科大学（岩手県）
国立病院機構仙台医療センター（宮城県）
宮城県立がんセンター（宮城県）
山形県立中央病院（山形県）
防衛医科大学校（埼玉県）
埼玉県立がんセンター（埼玉県）
国立がん研究センター東病院（千葉県）
国立がん研究センター中央病院（東京都）
がん・感染症センター都立駒込病院（東京都）
東京医科歯科大学（東京都）
がん研究会有明病院（東京都）
都立墨東病院（東京都）
神奈川県立病院機構神奈川県立がんセンター（神奈川県）
新潟県立がんセンター新潟病院（新潟県）
新潟県厚生連長岡中央綜合病院（新潟県）
燕労災病院（新潟県）
富山県立中央病院（富山県）
岐阜市民病院（岐阜県）
静岡県立総合病院（静岡県）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院（愛知県）
国立病院機構京都医療センター（京都府）
大阪大学医学部（大阪府）
近畿大学医学部（大阪府）
大阪府立病院機構大阪府立成人病センター（大阪府）
国立病院機構大阪医療センター（大阪府）
大阪医科大学（大阪府）
市立豊中病院（大阪府）
市立堺病院（大阪府）
兵庫医科大学（兵庫県）
兵庫県立がんセンター（兵庫県）
市立伊丹病院（兵庫県）
和歌山県立医科大学（和歌山県）
広島市立広島市民病院（広島県）
広島市立安佐市民病院（広島県）
国立病院機構四国がんセンター（愛媛県）
大分大学医学部附属病院（大分県）

Date of disclosure of the study information

2005

Year

06

Month

07

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/27280511

Number of participants that the trial has enrolled

Results

See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2002

Year

04

Month

04

Day

Date of IRB

Anticipated trial start date

2002

Year

06

Month

01

Day

Last follow-up date

2014

Year

07

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Jpn J Clin Oncol 2002; 32(9) 363-364

Registered date

2005

Year

06

Month

06

Day

Last modified on

2017

Year

11

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000018